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Biosimilars are beginning to gain momentum, even in the sluggish US market, evidenced by strong US and global sales reported this month by some of the top biosimilar players.

Drug maker Revance Therapeutics has announced positive results from its SAKURA clinical program for its daxibotulinumtoxinA, a novel botulinum toxin type A that it hopes will compete with brand-name Botox, or onabotulinumtoxinA.

Drug maker Formycon announced today that it has begun a phase 1 clinical trial of its proposed ustekinumab biosimilar, FYB202, referencing Stelara. Ustekinumab is the first available therapy to target the interleukin-12 and -23 pathway.

As biosimilars for innovator biologics advance, drug makers are seeking new indications for products in their portfolios as a means to protect their sales against oncoming—or existing—competition. This month saw 3 notable label developments for drugs made by Janssen, Alexion, and AbbVie.

When it comes to considering using biosimilars, savings for patients are providers’ top concern, followed by savings to the healthcare system at large. Yet physicians also rate their own confidence levels in biosimilars as a main hurdle for widespread biosimilar adoption.

The Center for Biosimilars® recaps the top stories for the week of October 21, 2019.

Writing in a viewpoint in JAMA, Walid F. Gellad, MD, MPH, and Chester B. Good, MD, MPH, both of the University of Pittsburgh, argue that the deep cost savings achieved in Europe for biosimilar adalimumab are unavailable to the United States because of settlements struck between AbbVie and the developers of all FDA-approved biosimilars.

The World Health Organization (WHO) and the International Generic and Biosimilar Medicines Association (IGBA), an umbrella organization with members including the Association for Accessible Medicines, Medicines for Europe, and a number of other national and regional generic and biosimilar organizations, have signed a memorandum of understanding.

A recent survey of employers regarding their concerns about growing healthcare costs reveals that some are looking to biosimilars as one method of controlling specialty drug spending.

While some data suggest that overall drug price increases may have moderated recently, prices for specific drugs continue to rise at rates above inflation.

On Friday, Humana filed a lawsuit in the Eastern District of Pennsylvania, alleging that 37 defendants engaged in a “far-reaching conspiracy” to “blatantly fix the price” of generic drugs.

Drug maker Pfenex announced this week that it has completed its comparative use human factors study for its follow-on teriparatide product, PF708, referencing the osteoporosis drug Forteo.

H.R. 3, The Lower Drug Costs Now Act, passed 2 committees in the House of Representatives Thursday, with a bipartisan amendment intended to boost uptake of biosimilars tucked inside.

Yesterday, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of Mundipharma’s pegfilgrastim biosimilar.

A trio of employer groups has formed a new partnership to advocate for policies that address the problem of high—and growing—drug costs.

The Center for Biosimilars® recaps the top stories for the week of October 14, 2019.

NeuClone said Thursday that it has begun dosing participants with its proposed ustekinumab biosimilar, referencing Stelara, in a phase 1 trial.

The Belgian Competition Authority, which contributes to implementing Belgium’s competition policy by addressing anticompetitive practices, announced that it is conducting inspections of some drug makers suspected of having implemented “restrictive practices aimed at limiting, delaying or even preventing the entry into the market or the expansion of biosimilar medicines competing with existing medicines."

As innovator biologics that have achieved blockbuster sales status reach or near the end of their exclusivities, biosimilar competition is close behind. This week, stakeholders got a closer look at how innovator drug companies are positioning themselves to maintain their sales in the face of such competition.

Drug shortages are an increasing problem—witness the news this week that the chemotherapy drug vincristine, a mainstay in fighting pediatric cancer, is in such short supply that doctors may be forced to start rationing, according to published reports. On Wednesday, the FDA said fiscal year 2018 saw a record number of generic drug approvals.

Genentech has announced that a phase 3 study of its brand-name rituximab, Rituxan, met its primary end point and demonstrated that treatment with rituximab is superior to treatment with mycophenolate mofetil in patients with moderate to severe pemphigus vulgaris (PV), a rate autoimmune disease that affects the skin and mucous membranes.

The MAGIC Act would amend the Affordable Care Act to allow chemically synthesized insulins to be approved under abbreviated new drug applications.

Among the biggest biosimilars news of this year was the launch of the first 2 anticancer biosimilars. This week on the podcast, we're speaking with an expert who's sharing her insight into these developments in the oncology space. Christina Corridon, MPH, MBA, is a principal at the professional services firm ZS Associates, where she is a leader in ZS' oncology practice and leads their biosimilars vertical. She joined us to talk about the state of play in the US biosimilars market, what we can learn from ongoing experience, and how sustainable the US market for biosimilars may be today.

While biosimilar stakeholders’ eyes have been on the recent launch of new products and on policy proposals that stand to impact these therapies, several new proposed biosimilar agents are making their way into clinical trials.

The Institute for Clinical and Economic Review (ICER), a nonprofit health technology assessment body, has issued an updated report on treatments for rheumatoid arthritis (RA) in which it says that the Janus kinase (JAK) inhibitor upadacitinib has a marginal clinical benefit over adalimumab and an "incremental cost-utility ratio falling below commonly cited thresholds.”

The Center for Biosimilars® recaps the top stories for the week of October 7, 2019.

Major drug companies poured hundreds of millions of dollars into nonprofit patient advocacy groups last year, as a fight over federal legislation to curb rising pharmaceutical prices is underway, Bloomberg Government reports.

A new KPMG report, commissioned by generic and biosimilar trade group Medicines for Europe, identifies some of the features of drug procurement in hospitals in different countries in Europe, explains how they impact biosimilar uptake, and gives recommendations to help biosimilars play a role in the strong—and growing—need to reduce spending in health systems.

A small, yet rapidly growing segment of commercially insured US patients have drug costs of more than $250,000 each year, and this group could account for 15% of all drug expenditures in the next 5 years.

Even as biosimilars of anti–vascular endothelial growth factor (anti-VEGF) agents are coming to market and advancing through the pipeline, a new agent that may have substantial benefits for patients with wet age-related macular degeneration (AMD) has been approved by the FDA: brolucizumab, which sponsor Novartis will sell as Beovu.